Implementing a multicomponent intervention to improve hypertension control in Central America: a cluster randomized trial in Guatemala

Health staff at health post on the rural area of Guatemala.

The cost-effective integration of noncommunicable diseases care into health systems, particularly at the first level of care, is essential to improve the prevention and control of such diseases.

Project summary

The first phase of this project assessed the needs, barriers, and knowledge gaps of the hypertension control program in the national health care system of Guatemala.

The second phase of this project, a cluster randomized trial will test the effect of a multi-level and multi-component intervention program within the primary healthcare system in Guatemala, on blood pressure (BP) control among hypertensive patients; will evaluate the adaptability, feasibility, fidelity, and sustainability of implementing the program in the primary health care system of Guatemala; and the cost effectiveness of such program in Guatemala in comparison to usual care. The comprehensive intervention, which includes protocol-based treatment using a standard BP management algorithm, team-based collaborative care, BP audit and Feedback, home BP monitoring, and health coaching on anti-hypertensive medication adherence and lifestyle modification, will last for 18 months.

This implementation research study presents high public health impact because it will generate urgently needed data on effective, practical, and sustainable intervention strategies aimed at reducing BP related disease burden in Central America and other low-and middle-income countries.
This project is led by the Institute of Nutrition of Central America and Panama (INCAP), its headquarters are located in Guatemala City.

Dr. Ramirez-Zea, the Principal investigator of the Guatemala project and his team at INCAP, introduce their project goals and activities.

Project goals

  1. To test whether a multilevel and multicomponent intervention program, integrated to the primary healthcare system in rural Guatemala, will improve hypertension control and lower systolic and diastolic blood pressure among patients with uncontrolled hypertension over an 18-month period compared to usual care.
  2. To evaluate the acceptability, adoption, feasibility, fidelity, reach, and sustainability of implementing the multicomponent intervention in patients, providers, and health districts.
  3. To evaluate the cost-effectiveness of the proposed multicomponent intervention program in Guatemala compared to usual care.
Exterior of a building with people waiting outside.
Exterior of a health facility at a rural area of Guatemala where our team meet with program participants.

Current status

The first phase of the project, the qualitative needs assessment, has been completed. The information gathered has been analyzed, a report has been issued, and results have been disseminated to the Ministry of Health of Guatemala. Currently, the team is working on a scientific article about the six building blocks of the health system related to hypertension. In addition, one article on stakeholder engagement has been published.

Based on the qualitative research results and the adaptation workshops carried out in five health areas, the intervention has been adapted to the Guatemalan context.

The 36 health districts where the project will be carried out have been selected and randomized. In addition, the study protocol has been submitted and approved by the IRB from the Ministry of Health, INCAP, University of Tulane, the Institute of Clinical Effectiveness and Health Policy, University of Colorado, NHLBI, and the Data Safety Monitoring Board. Training materials for training workshops have been validated and adapted to the Guatemalan context. Fieldwork started on July 2019.


We have selected five health areas for this study. Each health area comprises a geographical region called department. In agreement with the Ministry of Health (MOH), we decided to include two departments located in the Western (Huehuetenango and Sololá) and three in the Eastern (Baja Verapaz, Zacapa, and Chiquimula) regions of Guatemala.

Three departments have mainly Mayan indigenous populations (Huehuetenango, Solola, and Baja Verapaz and the other two mostly ladino communities (Zacapa and Chiquimula).


A hybrid effectiveness-implementation cluster randomized controlled trial (cRCT) will be conducted to test the effect of the multi-component intervention program on Blood Pressure (BP)control and the reach, adoption, implementation, sustainability, and cost-effectiveness of implementing this intervention among participants utilizing thepublic primary health system in rural Guatemala. We will randomly assign 36 health districts to the multi-component intervention (18 districts) and usual care (18 districts) stratified by geographic region.

Each health district will recruit 44 patients aged > 40 years with uncontrolled Hypertension (HTN). Each patient will be followed-up for 18 months. Monthly clinic/household visits will be conducted until the BP target is achieved in the active intervention group. Implementation outcomes will be measured every 6 months and assessments will be performed to improve implementation strategies. We will assess the six RE-AIM dimensions: reach, effectiveness, adoption, implementation and maintenance, and the feasibility and fidelity at the participants, provider, and system levels. Costs related to intervention and health care but not to the study data collection will be collected.

The incremental cost per additional percentage of patients achieving hypertension control at 18 months will be calculated using patient-level data. Usual care clinics will only receive an educational session for health providers on hypertensive clinical guidelines.

Two health staff standing facing the camera smiling.
Two of the program health staff at a health post in a rural area of Guatemala.


The dissemination plan is designed to translate, communicate, and implement the research findings to inform health policy, health practice, and public opinion. We will publish the study findings in international, national, and local medical and public health journals and make presentations at national and regional medical and public health professional meetings.

In addition, we will organize national and regional seminars/workshops and use mass media to promote the intervention program proven effective in our study. We will also design a dissemination toolkit that provides guidelines and examples of how to implement the program.

The Community Advisory Board (CAB) will be essential for designing and planning the dissemination of the intervention. We will disseminate findings of the study to the Central America Region through established networks in which INCAP participates.

Team Members

Our project has the support of 2 Principal Investigators, 7 Research Team members and 2 trainees.

Team on bus heading to the field.
  • Manuel Ramirez-Zea

    Manuel Ramirez-Zea

    Principal Investigator Guatemala project

    Dr. Manuel Ramìrez-Zea is the Contact principal investigator of Guatemala project, he is the Coordinator of the Research Center for the Prevention of Chronic Diseases (CIIPEC), Coordinator of the Laboratory of Physiology and Body Composition (LAFICC) and Coordinator of the Technical Unit of Nutrition and Chronic Diseases at Institute of Nutrition of Central America and Panama (INCAP).

  • Jiang He

    Jiang He

    Principal Investigator Guatemala project

    Dr. He is a Principal investigator on the Guatemalan project. He is a nationally and internationally well-known expert in the clinical, translational, and epidemiological research of cardiovascular and kidney diseases.

  • Dr. Vilma Irazola

    Research Director Center of Excellence for Cardiovascular Health
  • Meredith Fort

    Co-Investigator Department of Family Medicine, University of Colorado
  • Diego Hernandez

    Project Coordinator INCAP Research Center for the Prevention of Chronic Diseases
  • Pablo Gulayin

    Researcher Center of Excellence for Cardiovascular Health (CESCAS)
  • Laura Gutierrez

    Statistician Center of Excellence for Cardiovascular Health (CESCAS)
  • Daniela Moyano

    Researcher Center of Excellence for Cardiovascular Health (CESCAS)
  • Dina Roche

    Data Manager INCAP Research Center for the Prevention of Chronic Diseases
  • Kristyne Mansilla Dubón Research Assistant INCAP Research Center for the Prevention of Chronic Disease
  • Ana Lucia Peralta Garcia Research Assistant INCAP Research Center for the Prevention of Chronic Diseases

Publications and References

These references document the history of research studies by this team

  • FortMP, CardonaS, FigueroaJC, ArriagaC, BeratarrecheaA, Moyano, PalaciosE, IrazolaV, HeJ, and Ramírez-ZeaM. 2018 Translating ahypertension control program to Guatemala’s public primary health care system: priority needs andadaptations: Posterpresented at theNHLBI Saunders-Watkins Leadership Workshop. 2018 May

  • Fort MP, Paniagua-Avila A, Beratarrechea A, Cardona S, Figueroa JC, Martinez-Folgar K, Moyano D, Barrios E, Mazariegos BE, Palacios E, Irazola V, He J, Ramirez-Zea M. Stakeholder Engagement in the Translation of a Hypertension Control Program to Guatemala’s Public Primary Health Care System: Lessons Learned, Challenges, and Opportunities. Glob Heart. 2019 Jun;14(2):155-163.